India Pharmaceutical Regulatory Report 2010 + Appendix

Pacific Bridge Medical, January 2010, Pages: 148

The India Pharmaceutical Regulatory Report comprehensively covers all aspects of pharmaceutical regulations in India. It includes overviews of the laws and procedures on registration, manufacturing, distribution, price control, marketing, research and development, and intellectual property protection. It also includes an overview of the Indian pharmaceutical market and foreign involvement in the market up to 2009. How suited the country is to different kinds of market entry – such as manufacturing, sales, or research – is discussed in relation to the regulatory and market environment. As India’s pharmaceutical market is poised for steady growth, reaching an estimated $11 billion in 2008, understanding of Indian regulatory issues is crucial for success there.

I. Indian Economy Overview

II. Overview of Healthcare System
A. History
B. Healthcare Providers
C. Healthcare Spending
D. Conclusion

III. Pharmaceutical Industry
A. Market Profile
B. Industry Profile
C. Conclusion

IV. Regulatory Overview
A. Governing Legislation
B. Agencies

V. Drug Registration and Import
A. Overview
B. New Drug Registration
C. Import Registration
D. Import License
E. Adverse Event Reporting

VI. Manufacturing
A. Overview
B. Licensing
C. Good Manufacturing Practice

VII. Distribution
A. Overview
B. Licensing
C. Record-Keeping
D. Packaging and Labeling
E. Price Controls
F. Prescription Management

VIII. Clinical Trials and R&D
A. Overview
B. Restrictions on Clinical Trials
C. Global Clinical Trials
D. Licensing and Monitoring
E. Good Laboratory Practice
F. Accreditation of Testing Laboratories

IX. Intellectual Property Protection
A. History
B. Patent Applications
C. Remaining Restrictions

X. Drug Advertising

XI. Conclusion

XII. Appendices:
Procedural Flowcharts
I. Importing drugs
II. Manufacturing drugs
Official Forms
III. Summary
IV. Drug registration
V. New drug
VI. Manufacturing license
VII. Import license
VIII. Wholesale license
Schedule Y Excerpts
IX. Study report format
X. Animal toxicology
XI. Animal pharmacology
XII. Informed consent form
XIII. Adverse event report form
Drug Lists
XIV. Schedules C and C(I)
XV. Schedule G
XVI. Schedule H
XVII. Schedule K
XVIII. Schedules P and P(I)
XIX. Schedule X
XX. Drugs listed in Narcotic Drugs and Psychotropic Substances Act
XXI. Drugs subject to price control
XXII. Drug Quality Standards
XXIII. Listing of CROs in India
XXIV. Healthcare

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